Gisela Leon EAS Consulting
In May 2016, the FDA published two final rules about nutrition labeling, one focused on revisions to food and supplement nutrition labeling requirements (21 CFR 101.9 and 101.36)1,2, and the other focused on serving sizes of foods that can reasonably be consumed in one eating occasion (CFR 101.12). These rules were the first major overhauls of nutrition labeling requirements since the regulations that implemented the 1994 Dietary Supplement Health and Education Act.
For many companies, the compliance date for these final rules is rapidly approaching. The FDA has set the compliance date to be the date on which the product is labeled. Companies selling products in the US that have more than $10 million in food sales, must comply with the new regulations by January 1, 2020, while smaller companies have an additional year to comply3. To help manufacturers understand the updated nutrition labeling requirements in 21 CFR 101.9 and 101.36, the FDA has also published one additional final rule, six guidances for industry, and two draft guidances for industry.
Updates
The updates to nutrition labeling requirements for dietary supplements mostly affect the new daily values for nutrients. Almost all daily values have changed, and there are now four codified subpopulations: the general population (persons 4 years and older), infants, toddlers, and pregnant and lactating women. While calculating the new daily value percentages for declaration involves a lot of workforce time and money, other changes to the nutrition labeling requirements present different challenges.
The first major change is the new definition of dietary fiber. The FDA defined dietary fiber as certain naturally occurring fibers that are “intrinsic and intact” in plants and added isolated or synthetic non-digestible soluble and insoluble carbohydrates that the agency has determined have beneficial physiological effects on human health. For the past two years, industry has been held in suspense as the FDA reviewed numerous studies to confirm beneficial physiological effects of isolated or synthetic non-digestible carbohydrates. A recent guidance for industry finally acknowledged inulin, one of the predominantly used fibers, as a dietary fiber. The initial list of seven isolated fibers in the final rules has now increased to 15 acknowledged dietary fibers, including the large groups of mixed plant cell-wall fibers, inulin, and inulin-type fructans. The second major change is the requirement for declaration of added sugars and the establishment of a new daily value of 50 grams. This change is particularly important for dietary supplements that have a serving size larger than a single tablet or capsule.
The third major change is to the units of measure for vitamins A, D, and E. The agency updated the daily values and eliminated the use of international units (IUs). The conversion from IUs to micrograms or milligrams represents a challenge, because many supplier and raw material specifications are still based on IUs. Without knowing the actual amount added as the dietary ingredient, converting from IUs to micrograms or milligrams is difficult.
Vitamins A and C are no longer mandatory, so the mandatory nutrients in the vitamin and mineral category are now vitamin D, calcium, iron, and potassium. The declaration of folate has been changed so that the regulation now includes a defined potency for folic acid. Therefore, if folic acid is added as the source of folate, the amount of folic acid and folate must be declared. The percent daily value for folate is based on the calculated folate amount.
One change that does not influence the declaration in the supplement facts panel is the requirement to keep records for added sugar, dietary fiber, vitamin E, and folate. Manufacturers must keep records in cases that use a mixture of both naturally occurring and added or synthetic ingredients but aren’t required to keep records in cases that use only naturally occurring or only added or synthetic ingredients.
Unlike the nutrition facts panel for conventional foods, the supplement facts panel format has not changed. For example, for products with no added sugar, the new supplement facts panel requires the same space as before. As a result, the changes to the supplement facts panel are theoretically easier and faster to make than the changes for conventional foods.
After making all these calculations, the next challenge is to verify whether the new daily values and the amounts used in the product enable the manufacturer to continue to make certain nutrient content or health claims. The daily values for vitamin C, vitamin D, vitamin K, calcium, magnesium, manganese, phosphorus, and potassium went up. Therefore, it’s possible that the current dosage in the dietary supplement will no longer meet the 10 percent daily value requirement for a good source nutrient content claim. The daily values went down for biotin, niacin, pantothenic acid, riboflavin, thiamin, vitamin A, vitamin B6, vitamin B12, vitamin E, chloride, chromium, copper, molybdenum, selenium, and zinc. For these nutrients, the new daily values may represent an opportunity to make nutrient content claims without having to adjust the dosage.
The 2016 final rules have kept the labeling world busy over the last two years, and the industry continues to work hard to meet the looming compliance date. Because compliance with the final rules is compulsory, dietary supplement manufacturers that have yet to begin assessing the state of their labels, declarations, and required revisions would be wise to do so quickly.
References
1. www.regulations.gov/document?D=FDA-2012- N-1210-2151.
2. www.federalregister.gov/documents /2018/ 12/21/2018-27431/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels-technical-amendments.
3. www.fda.gov/downloads/Food/GuidanceRegula tion/GuidanceDocumentsRegulatoryInformation/ UCM535372.pdf.
Gisela Leon is an independent consultant for EAS Consulting Group, Alexandria, VA (571 447 5500, www.easconsultinggroup.com). She has more than 33 years of experience in international labeling, including FDA labeling requirements for food, dietary supplements, and cosmetics; European food laws; and multi-language labeling. Leon holds a master’s degree in food technology engineering from the Technical University of Munich, a DGQ audit-specialist certification from the German Institute for Quality, and an MBA from George Mason University. For more than 20 years, she was director of quality management and labeling compliance at Schöller Lebensmittel.